Randomised controlled study of dose reduction and withdrawal strategies of adalimumab and etanercept in rheumatoid arthritis: saving costs at what expense?

Completed

• Conditions: chronic arthritis; rheumatoid arthritis; 10023213

• Registration Number: NL-OMON38325
• Lead Sponsor: Sint Maartenskliniek

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2014-05-21
• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 180

Inclusion Criteria

- Rheumatoid arthritis (either 2010 ACR RA and/or 1987 RA criteria and/or clinical diagnosis of the treating rheumatologist, fulfilled at any time point between start of the disease and inclusion)
- Using either adalimumab or etanercept (all dose/interval regimens, all background medication including DMARDs and corticosteroids up to 5 mg, higher doses of steroids should be reduced first)
- 6 months of stable low disease activity while using adalimumab or etanercept (operationalised by either a DAS28 < 3.2 or judgment of low disease activity by rheumatologist at at least two subsequent visits)
- 6 months stable treatment with adalimumab or etanercept (previous dose reduction/interval increase is allowed when more than three months ago) and stable DMARDs and corticosteroids for more than 4 weeks

Exclusion Criteria

- Co morbidity that also requires treatment with anti-TNF and thus prevents dose reduction

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Cumulative incidence of patients fulfilling prespecified loss of<br /><br>response/flare criteria in the intervention and the usual care group after 9<br /><br>months and after 18 months of follow up.<br /><br><br /><br>- Cost effectiveness (cost minimisation) ratio between intervention group and<br /><br>usual care group for the 9 month induction phase and for the 12 months<br /><br>maintenance phase.<br /><br><br /><br>- Predictive values/characteristics of a prediction model including (change in)<br /><br>serum drug levels and PET arthritis.<br /><br><br /><br>- Proportion of patients with a change in modified Sharp-van der Heijde Score><br /><br>MCIC in the intervention and usual care group.</p><br>